As an alternative to invasive-type surgeries whereby a physician creates an incision to access a desired location in the patient's body, many minimally invasive medical procedures are being performed using flexible elongated medical devices that are inserted into a patient's body. These flexible elongated medical devices include guide wires, catheters, flexible stents, tubing, wires, fiber optic equipment, drains, balloons, and so forth. Due to their nature, these flexible elongated medical devices can be awkward to handle, organize, and store, and there is currently no effective way to securely and gently hold a flexible elongated medical device in between uses during a medical procedure.
An example will be illustrative of the context in which there is a need for this invention. Certain minimally invasive medical procedures involve the insertion of a catheter into the human body. In order to insert a catheter into the appropriate portion of the body, which will be a tubular structure of interest such as an artery, a guide wire for the catheter must first be inserted. Initially, a needle is used to enter the body, through the patient's skin and into the tubular structure of interest. A guide wire is then inserted through the needle and into the body, after which the needle is removed. The guide wire is pushed through the tubular structure of interest, and once the guide wire is positioned in the desired location, another flexible elongated medical device, such as a catheter, may be inserted over the guide wire, the guide wire thereby “guiding” the other flexible elongated medical device in use into the appropriate position in the tubular structure inside the patient's body. Once the flexible elongated medical device is in place, the guide wire is then removed or exchanged so that the next step in the desired medical procedure may be performed, such as obtaining a biological sample, delivering an agent, or deploying a medical device such as a stent.
Flexible elongated medical devices, such as guide wires and catheters, are of various lengths, calibers, stiffnesses, and materials, depending on the use for which they are intended. Because of their different properties, several different flexible elongated medical devices are used during a single procedure, and many of those individual flexible elongated medical devices are used and reused during a single procedure. While in use during a procedure, a flexible elongated medical device is removed from its sterile packaging and is inserted into the patient, with a portion of the flexible elongated medical device remaining outside of the patient's body such that the flexible elongated medical device can be removed. The flexible elongated medical devices are often two (2) meters long and have a natural tendency to remain straight. Problems arise in finding a means for securely and gently holding, and maintaining the sterility of, flexible elongated medical devices when they are outside of the patient's body within the sterile procedural field and in between uses during a single procedure.
At the present time, the handling and management of flexible elongated medical devices outside of the patient's body during a procedure is both awkward and inefficient. To be managed, a flexible elongated medical device that is removed from the patient's body after use but which may be used again in the same procedure is looped around itself by hand, as would be an extension cord, so that it is in a coiled condition. The portion of the flexible elongated medical device held in a coiled condition is then discouraged from springing into its naturally straight configuration in a number make-shift of ways, such as (a) by placing the coiled flexible elongated medical device in a bowl and allowing it to push out against the sides of the bowl (which can be especially messy when using multiple flexible elongated medical devices, as a number of flexible elongated medical devices may accumulate in the bowl, making it difficult to locate a specific device and remove it from the bowl for use when needed during the procedure without tangling with other flexible elongated medical devices or dislodging other flexible elongated medical devices from the bowl), (b) by winding the loose end of the flexible elongated medical device around the coiled portion (which can be difficult to control), and/or (c) by placing a weighted object, such as a sterile towel, on the coiled portion to prevent it from uncoiling or springing open (which can be difficult to control and bulky, with towels or other weighted objects lying on the operative field). The flexible elongated medical device that is coiled and discouraged from springing into its naturally straight configuration is put aside by the technician within the sterile procedural field when not in use so that another flexible elongated medical device may be used; it is likely that the flexible elongated medical device that is coiled and discouraged from springing into its naturally straight configuration may be used again during the same procedure. Before reuse, the technician may need to ensure that the flexible elongated medical device is moist or wiped clean, depending on the particular flexible elongated medical device being reused and its particular use.
The make-shift ways of discouraging coiled flexible elongated medical devices from springing into straight configurations are unstable and unreliable. As stated previously, the natural state of a flexible elongated medical device is for it to be straight, so it is resistant to passive coiling. When it is looped in a coiled condition, which is how these devices are managed during procedures, potential energy is stored in the coiled condition much like potential energy is stored in a spring. These devices have a tendency to expand outwardly in a radial manner, pushing to be straight, and they can “spring open” unintentionally if not prevented from doing so. There is currently no way to reliably hold these devices in place while not in use.
Inefficiencies, inconvenience, waste, and increased cost therefore result from these make-shift techniques of managing flexible elongated medical devices during procedures. It can take time for a technician to secure a flexible elongated medical device in between the device's uses with these make-shift techniques, as they need to be adjusted just right to hold the device that is pushing to be straight. These techniques can be burdensome and can add time to the procedure. Further, a flexible elongated medical device stored outside of the patient's body during a procedure in this unstable way can spring open and become unacceptably contaminated or otherwise damaged by falling onto the floor or coming into contact with an unsterile surface in between uses, thereby compromising sterility or function. When this happens, time must be taken to thoroughly clean the contaminated flexible elongated medical device for reuse or the flexible elongated medical device may need to be discarded (whether due to contamination or damage) and replaced with an identical device immediately rather than being able to be reused, causing unnecessary delay as the medical team must search for a new replacement device and prepare such device for use. Replacement of accidentally contaminated or damaged flexible elongated medical devices can add to the expense of a medical procedure by increasing the cost of materials and procedure time. Additionally, delay while searching for a new flexible elongated medical device at a critical point during a procedure may place a patient's life and/or health at risk and increase the potential liability for medical personnel if something goes wrong during the procedure. Further, the mess and inconvenience of having no efficient way to securely and gently hold flexible elongated medical devices during procedures can be distracting and add to procedure time, thereby increasing cost.
The current invention solves these problems by providing an apparatus which may be used to securely and gently hold a flexible elongated medical device between uses during a medical procedure in a reliable, compact, and efficient way.
The foregoing objects and advantages of the invention are illustrative of those that can be achieved by the present invention and are not intended to be exhaustive or limiting of the possible advantages which can be realized. Thus, these and other objects and advantages of the invention will be apparent from the description herein or can be learned from practicing the invention, both as embodied herein or as modified in view of any variation which may be apparent to those skilled in the art. Accordingly, the present invention resides in the novel methods, arrangements, combinations, and improvements herein shown and described.